Sterile connector for conduits

ABSTRACT

A sterile connector for the end of a conduit employed in the passage of blood or of blood components which comprises a resilient, deformable gasket disposed about the terminal end of a conduit, a continuous, removable yieldable flexible strip material, a portion of which is removably adhered to said gasket and overlies the end of said conduit, said strip material having a free end, said strip material being in a generally U-shaped configuration, whereby a force applied to the free end thereof withdraws the entire strip material to expose the end of said conduit; a method of joining the ends of two conduits together in a sterile manner so that blood or its components can pass therethrough which comprises providing each end with a connector as described above, arranging them in face-to-face alignment so that the ends of the conduit are in registry, drawing the connectors together so that the gasket of each connector is deformed inwardly and so that the free ends of the strip material are substantially parallel and withdrawing the strip material from each of said connectors at the same time; a pair of conduits joined together by a pair of facing connectors as described above.

United States Patent 1 Rowe et a1.

[ 1 Feb. 11, 1975 I STERILE CONNECTOR FOR CONDUITS [731' Assignee: UnionCarbide Corporation, New

York, N.Y.

22 Filed: Mar. 29, 1973 21 Appl. No.: 346,087

[52] US. Cl. 285/363 [51] Int. Cl. F161 17/00 [58] Field of Search285/364, DIG. 2, DIG. ll,

285/DIG. 12, 420, 363; 138/89, 96 R [56] References Cited UNITED STATESPATENTS 1,956,683 5/1934 Hewitt 285/363 X 2,453,669 11/1949 Meneses285/420 X 3,018,120 l/l962 Vann 285/363 X 3,044,479 7/1962 Meyer etal....,. 138/96 R X 3,215,456 11/1965 Schmid 285/420 X 3,228,096 1/1966Albro 285/363 X 3,372,949 3/1968 McLay 285/364 3,583,460 6/1971 Faust etal. 138/89 FOREIGN PATENTS OR APPLICATIONS 1,419,014 10/1965 France285/DIG. 12 1,072,026 12/1959 Germany 285/364 Primary Examiner-Alfred R.Guest Attorney, Agent, or FirmMaurice W. Ryan [57] ABSTRACT A sterileconnector for the end of a conduit employed in the passage of blood orof blood components which comprises a resilient, deformable gasketdisposed about the terminal end of a conduit, a continuous, removableyieldable flexible strip material, a portion of which is removablyadhered to said gasket and overlies the end of said conduit, said stripmaterial having a free end, said strip material being in a generally U-shaped configuration, whereby a force applied to the free end thereofwithdraws the entire strip material to expose the end of said conduit; amethod of joining the ends of two conduits together in a sterile mannerso that blood or its components can pass therethrough which comprisesproviding each end with a connector as described above, arranging themin face-to-face alignment so that the ends of the conduit are inregistry, drawing the connectors together so that the gasket of eachconnector is deformed inwardly and so that the free ends of the stripmaterial are substantially parallel and withdrawing the strip materialfrom each of said connectors at the same time; a pair of conduits joinedtogether by a pair of facing connectors as described above.

5 Claims, 5 Drawing Figures STERILE CONNECTOR FOR CONDUITS BACKGROUND OFTHE INVENTION FIELD OF THE INVENTION DISCUSSION OF PRIOR ART In manyfields, such as medicine, pharmacy and chemistry, it is often necessaryare transfer fluids from one receptacle to another while keeping suchfluids absolutely uncontaminated by extraneous materials, even those aselusive as air-borne spores or gaseous air pollutants. As an example, inthe handling of human blood, it is frequently necessary or desirable toseparate the blood into a number of its components, or to freeze theblood to be able to store it for long periods. Whenever a new connectionmust be made, however, to transfer the blood or blood component intoanother receptacle for washing, centrifuging or other processing, thepossibility of contamination, even from air-borne materials, is present.Such a connection is conventionally accomplished by inserting a sterileneedle attached by tubing to one receptacle into a sterile diaphragmconnected to the other receptacle. In carrying out such a connection,the connector elements are subjected to possible contamination fromair-borne bacteria, spores, etc., and from mishandling by thetechnician. As a consequence of this possibility, blood or bloodcomponents which have been subjected to a transfer operation by means ofthe conventional type of connector have been limited by governmentregulation to a useful life of 24 hours as opposed to a useful life of21 days for blood which has not been so handled.

OBJECTS OF THE INVENTION A prime object of this invention is to providea simple system for connecting two blood receptacles in a sterile,fool-proof manner, so that the useful life of the transferred blood orblood component can be extended to more than 24 hours. This same systemalso finds application in other fields where complete freedom fromcontamination is required in the transfer of fluid from one receptacleto another.

SUMMARY OF THE INVENTION The objects of the invention are accomplishedby a sterile connector attached to the end of a conduit which connectorcomprises a resilient, deformable gasket disposed about the terminal endof the conduit, a continuous, removable, yieldable, flexible stripmaterial, a portion of which is removably adhered to the gasket andoverlies the end of the conduit, the strip material having a free endand, being in a generally U- shaped configuration, whereby a forceapplied to the free end thereof withdraws the strip material to exposethe end of the conduit.

In a particularly desirable embodiment, the gasket is supported by agenerally T-shaped flange material disposed about the conduit andinwardly of the gasket, that is on the side opposite the end of theconduit. It

should be understood that the flange member is circular but has aT-shaped cross-section, as will appear from the disclosure below.

The conduits are joined in a simple, sterile and foolproof mannerwhereby contamination is precluded by a method which comprises providingeach end of conduit to be joined with a connector as described above,arranging the connectors in face-to-face alignment so that the ends ofthe conduit are in registry with one another, drawing the connectorstogether, with conduit, so that the gasket of each connector is deformedinwardly and so that the free ends of the strip material aresubstantially parallel, and withdrawing the strip material from each ofsaid connectors at the same time. Preferably, the connectors are drawntogether and held together in compressed clamping relationship by asuitable clamp member which will hold the gaskets in deformed conditionwhile the strip material is withdrawn therefrom. Preferably, the stripmaterial is withdrawn as a unit, i.e., the strip materials are broughttogether in alignment with one another and are withdrawn by pulling thesame.

The strip material can have any suitable adhesive substance on its sidefacing the gasket. Additionally, at least on the side facing outwardly,it can have an adhesive substance which will facilitate the securementof the free end at its outer face to the free end of a facing stripmaterial of a connector disposed about an end of. a conduit to be joinedto the first conduit of the first connector. This facilitates withdrawalof the strip material as a unit. It will be appreciated, therefore, thata continuous strip material having an adhesive substance on one sidethereof can be utilized. Toward one end of the strip material, theadhesive will secure the strip material to the gasket. Toward the otherend thereof, i.e., on the other end of the U-shaped configuration, thestrip material will have its adhesive facing outwardly so as tofacilitate its securement to the free end of an opposing strip material,whereby the same can be withdrawn as a unit.

The principle of the present invention is to superimpose two diaphragms,one attached to each end of two similar connector fittings, and, whilethey are held tightly together in an air-tight manner, to invaginatethem by pulling them in upon themselves and thus withdrawing them fromthe connector assembly. In this way, the outer contaminated surfaces ofthe two diaphragms are removed from the assembly without ever havingbeen exposed to the internal surfaces of the connector.

BRIEF DESCRIPTION OF THE DRAWINGS The connector of the invention and themethod of carrying out the invention can be more readily understood andappreciated when reference is made to the accompanying drawings inwhich:

FIG. 1 is a side elevation of the connector in section;

FIG. 2 is an end view of the connector of the invention taken from theright of the view depicted in FIG. 1. In FIG. 2 the connector is nolonger in section;

FIG. 3 is a side elevation of a pair of connectors in section showingthem about to be connected. In FIG. 3 there is shown a clamping meansdisposed about a flange member as will appear from the discussion below;

FIG. 4 is an end view similar to FIG. 2 showing the disposition of theclamp member about the flange;

FIG. is a view similar to FIG. 3 showing the disposition of the gasketupon withdrawal of the strip material. In FIG. 5 the strip material hasnot been entirely withdrawn from the connector assembly.

DESCRIPTION OF SPECIFIC EMBODIMENTS Referring to the drawing, FIG. 1shows an example of the fitting that is attached to the flexible tubingor conduit 1 leading from a receptacle. An annular flange 2 of plasticor other suitable material is attached to the tubing. A compressiblegasket 3 made from an appropriate elastomeric or plastic compound suchas a foamed vinyl is firmly adhered to the face of the flange. Adiaphragm 4, is the form of a generally U-shaped strip material,consisting of a thin strong film of plastic, such as polyvinyl chlorideor polyester or other appropriate material, is attached to the gasketwith an easyreleasing type of adhesive. The diaphragm 4 has a tab orfree end 5 of its own material which when folded back upon itselfextends beyond the gasket to act as a draw-pull. The entire assembly isfactory-sterilized so that all enclosed areas are completely free of anycontamination.

Referring to FIG. 3, two of the fittings described in FIG. 1 are broughttogether so that the folds 6 of the U-shaped strip material in therespective diaphragms are together and the tabs 5 are superimposed uponeach other and extend out beyond the gasket. The fittings have markingsor extended lips so that they can not be brought together in any otherjuxtaposition than as shown. The assembly of the two fittings is themclamped together by an appropriate mechanical means 7, i.e., aspring-loaded clamp or a snap-fitting bail, so that the two gaskets arecompressed against each other with a predetermined amount of pressure toform a tight seal. The extended diaphragm tabs 5 are then held togetherby the technician and are pulled out manually as one unit from betweenthe elastic gaskets. In so doing, the internal diaphragms areinvaginated or pulled in upon themselves and withdrawn from theconnector assembly while the elastic gaskets continue to maintain atight seal.

FIG. 5 is an illustration of the withdrawal when it is partiallycomplete. Thediaphragms are discarded when withdrawn, leaving a tightsterile connector assembly ready for the transfer of fluid.

From the above description it is apparent that by a simple andinexpensive means there is provided a sterile and relatively fool-proofconnection between conduits. These conduits can then readily be utilizedfor the passage of blood, blood components, or any fluid desired to behandled under and maintained in sterile condition. The connector meanscan readily be assembled to the ends of conduits by simple means. Thelikelihood of contamination is markedly reduced, if not totallyeliminated.

It will be apparent that the present invention is capable of numerousdifferent embodiments and variations. Any substance approved for use incontact with the fluid to be transferred can be used, provided, ofcourse. that it has the physical characteristics required as outlinedabove. This includes the use of numerous plastics, elastomers, or othermaterial approved for safe use with human blood. Accordingly, it shouldbe understood that the terms and expressions used herein have been usedfor the purposes of illustration and not of limitations, as there is nointention, in the use of such terms and expressions, of excluding anyequivalents, or portions thereof, as various modifications anddepartures from the above disclosure will be apparent to one skilled inthe art.

What is claimed is: I

l. A sterile connector for the end of a conduit which connectorcomprises a resilient, deformable gasket disposed about the terminal endof a conduit, 21' continuous, removable, yieldable, flexible stripmaterial, a portion of which is removably adhered to said gasket andoverlies the end of said conduit, said strip material having a free end,said strip material being in a generally U-shaped configuration; wherebya force applied to the free end thereof withdraws the entire stripmaterial to expose the end of said conduit.

2. A sterile connector according to claim 1 having a flange envelopingthe end of a conduit, said gasket being attached to said flange.

3. A sterile connector according to claim 2 wherein said flange has aT-shaped cross-section.

4. A sterile connector according to claim 1 wherein an adhesivesubstance is disposed on said strip material on the side between saidgasket and said strip material.

5. A sterile connector according to claim 4 wherein the adhesivesubstance continues through the entire configuration of strip materialon at least one side thereof.

1. A sterile connector for the end of a conduit which connectorcomprises a resilient, deformable gasket disposed about the terminal endof a conduit, a continuous, removable, yieldable, flexible stripmaterial, a portion of which is removably adhered to said gasket andoverlies the end of said conduit, said strip material having a free end,said strip material being in a generally U-shaped configuration; wherebya force applied to the free end thereof withdraws the entire stripmaterial to expose the end of said conduit.
 2. A sterile connectoraccording to claim 1 having a flange enveloping the end of a conduit,said gasket being attached to said flange.
 3. A sterile connectoraccording to claim 2 wherein said flange has a T-shaped cross-section.4. A sterile connector according to claim 1 wherein an adhesivesubstance is disposed on said strip material on the side between saidgasket and said strip material.
 5. A sterile connector according toclaim 4 wherein the adhesive substance continues through the entireconfiguration of strip material on at least one side thereof.